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Associate Vice President, Regulatory CMC Diversified Brands Franchise Lead - NR_Diversified Bra[...]

Company: Merck
Location: Jersey City
Posted on: September 15, 2020

Job Description:

We are one company, Merck & Co., Inc., Kenilworth, New Jersey, USA but we operate under two different corporate brand names.We are known as

Merck & Co., in the United States, Canada & Puerto Rico. We are known as MSD outside the United States, Canada & Puerto Rico.

Associate Vice President, Regulatory CMC Diversified Brands Franchise Lead - NR_Diversified BrandsCMC Lead_Aug 27 This job is available in 2 locations Job Type Full time

Merck & Co. Inc. (headquartered in Kenilworth, NJ), has made the decision to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses to form a new, independent company. This new company, named “Organon”, will become an independent, publicly traded company in 2021 with its global and US headquarters to be based in Jersey City, NJ. We expect that additional Organon sites will be in the general vicinity of current Merck locations.

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For this exciting new opportunity, we are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership. Working together, we will make a significant impact on the health and lives of people around the world.

For more information about Organon, please click here .

Job Description

Reporting to the Head of Regulatory CMC, the Associate Vice President (AVP) will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for products within the Diversified Brand portfolio. This large and growing portfolio of pharmaceutical products for cardiovascular, respiratory, dermatology and pain indications, including oral solid dosage forms, sterile injectable and topical products. The AVP is accountable for delivery of applicable CMC sections for life-cycle maintenance submissions, post-approval changes, Agency Background Packages, and responses to Agency questions for global markets for existing products and Worldwide Marketing Applications for new product registrations.

The AVP will drive alignment with partner organizations within Manufacturing, Research and Development, and Commercial to assure the optimal regulatory pathways are implemented to deliver on business objectives and compliant supply. The AVP is accountable to identify and communicate CMC regulatory risks and effectively define mitigation strategies and regulatory plans in partnership with senior leaders and stakeholders. The AVP will represent the CMC organization in executive forums to drive overall strategy for the Diversified Brands portfolio.

Critical to this role is the ability to lead a diverse global team and to effectively attract, recruit and retain talent. The individual leading this team, will need to demonstrate an ability to navigate through complexity and flexibly allocate internal and external resources to meet dynamic business priorities, while keeping the team motivated, engaged and providing career development opportunities. He/she will lead a team of approximately 40-50 permanent employees and external vendor resources to deliver on corporate priorities.

Responsibilities:

Accountable for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.

Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to develop risk-based solutions to problems and mitigate potential regulatory challenges.

Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Executive Leadership in manufacturing, research and development, commercial, and business development areas.

Embody the Organon Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.

Actively coach team members to develop robust regulatory strategies, embed risk management in ways of working and to develop broad enterprise mindset.

Continuously evaluate and develop talent within the team and prepare a succession plan.

Use recognition and rewards to promote team and organizational collaboration.

Set a vision for the team and hold employees accountable for execution of the organization’s policies and procedures.

Flexibly manage and allocate resources to support execution and delivery of prioritized work to meet business commitments.

Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization.

Advocate for the CMC organization requirements and positions in executive leadership forums.

Monitor the global regulatory environment to identify changes with potential CMC impact and works closely with the Head of CMC to implement updates to CMC strategic approaches, processes and procedures.

Skills:

Develop and maintain expert knowledge of current global regulatory CMC requirements for investigational submissions, original registrations and post-approval changes. This includes knowledge of the regulatory guidance for pharmaceutical and combination products and the associated technologies.

Coach team to identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making and appropriate risk tolerance.

Collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills.

Influence innovative and scientifically sound approaches to gain approval.

Participate in the development of CMC business processes or organizational initiatives as needed.

Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of submissions.

Develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents. Utilize expert knowledge and reputation to influence the content of new Industry Association Whitepapers, Health Authority guidance & regulations. Present and participate at industry meetings.

Education Requirement:

Degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, Pharmacy

Required:

Minimum 20 years pharmaceutical industry experience; 15 years with an advanced degree.

Minimum 10 years working in Regulatory CMC, with progressive experience in leading global programs across the product life cycle, and minimum 10 years managing people.

Preferred:

The ideal candidate will have strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance) and experience managing a team of Regulatory CMC professionals.

A candidate with strong experience in small molecule pre/post approval expertise is highly preferred.

The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.

He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.

The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.

The candidate must have demonstrated experience in building, rewarding and retaining key talent.

He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.

The candidate must be proficient in English; additional language skills are a plus.

#NewCo

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement?

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular Relocation:

Domestic/International VISA Sponsorship:

Yes Travel Requirements:

10% Flexible Work Arrangements:

Remote Work Shift:

1st - Day Valid Driving License:

No Hazardous Material(s):

Number of Openings:

1

Requisition ID: R72636

Email this job to: Organon will improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas.

We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s well-being

Invest in innovations to support women’s well-being, fueled by our leading contraceptives and fertility business.

Establish a leading position in biosimilars, focusing on oncology and inflammatory diseases, and being a partner in the commercialization of biosimilars worldwide.

???????Realize the value of trusted dermatology, pain and cardiovascular portfolio.

Not ready to apply? This careers website is intended for Residents of the United States, Canada & Puerto Rico. Residents in other markets, please visit our MSD Careers page .

Information on this site is for the purpose of presenting career opportunities at our organization and give our audience a view of our culture, diversity and growth opportunities.

Our Company is an equal opportunity employer, Minority/Female/Disability/Veteran, proudly embracing diversity in all of its manifestations.

Keywords: Merck, Jersey City , Associate Vice President, Regulatory CMC Diversified Brands Franchise Lead - NR_Diversified Bra[...], Other , Jersey City, New Jersey

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